BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CYBERRX MODEL 7200

    K Number: K934434 · Decision Jan 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    48
    Applicant Total
    1
    Review Days
    519

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    Basic Information

    Device Name
    CYBERRX MODEL 7200
    K Number
    K934434
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.1400
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cybermed Control Systems, Inc.
    Date Received
    August 23, 1993
    Decision Date
    January 24, 1995
    Product Code
    FFT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FFT Electrode, Ph, Stomach

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